Data / Medical devices / Radioimmunoassay, C-Peptides Of Proinsulin
Radioimmunoassay, C-Peptides Of Proinsulin (JKD): 28 FDA-registered makers in 10 countries
28 establishments in 10 countries are registered with the FDA to make Radioimmunoassay, C-Peptides Of Proinsulin (product code JKD, Class 1, 21 CFR 862.1135). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on February 13, 1996, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JKD
- Device class
- 1
- Regulation
- 862.1135
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| China | 6 |
| United Kingdom | 3 |
| Germany | 3 |
| Japan | 2 |
| Spain | 1 |
| South Korea | 1 |
| Italy | 1 |
| Belgium | 1 |
| Sweden | 1 |
Makers of Radioimmunoassay, C-Peptides Of Proinsulin
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | March 23, 1995 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | March 23, 1995 | 0 | 0 | 0 | api.fda.gov |
| Ansh Labs, LLC | Webster, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Laboratory Products Company | Salem, NH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Laboratory Systems (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Hotgen Biotech Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boditech Med Inc. | Chuncheon Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Medical Diagnostics Corporation Fuji Plant. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Deutschland GmbH | Dietzenbach Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Italia S.p.A. | SALUGGIA Vercelli, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSource ImmunoAssays, SA | Louvain-La-Neuve Brabant Wallon, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Getein Biotech, Inc. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invitron | Monmouth Monmouthshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mercodia AB | Uppsala, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 13, 1996. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.